Applies to the following strengths: 2.5 mg; 5 mg; 0.8 mg
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Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Hyperprolactinemia
Initial: 1.25 mg to 2.5 mg orally daily.
Titration: Add 2.5 mg orally, as tolerated, to the treatment dosage every 2 to 7 days.
Maintenance: 2.5 mg to 15 mg orally daily.
Usual Adult Dose for Acromegaly
Initial: 1.25 mg to 2.5 mg orally once daily, with food, at bedtime for 3 days.
Titration: Add 1.25 mg to 2.5 mg orally, as tolerated, to the treatment dosage every 3 to 7 days.
Maintenance: 20 mg to 30 mg orally daily
The maximum dosage should not exceed 100 mg/day.
Usual Adult Dose for Parkinson's Disease
Initial: 1.25 mg twice daily with meals.
Titration: Add 2.5 mg/day, with meals, to dosage regimen every 14 to 28 days.
Maximum dosage: 100 mg/day.
Usual Adult Dose for Diabetes Type 2
For the Cycloset (R) trade name of bromocriptine only:
Initial: 0.8 mg orally daily taken within two hours after waking in the morning with food
Titration: Increase by 0.8 mg weekly as tolerated
Maintenance: 1.6 to 4.8 mg orally daily taken within two hours after waking in the morning with food
The maximum dosage should not exceed 4.8 mg daily.
Usual Pediatric Dose for Hyperprolactinemia
11 to 15 years old:
Initial: 1.25 mg to 2.5 mg orally daily.
Maintenance: 2.5 mg to 10 mg orally daily.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Patients should be evaluated frequently during dose titration to determine the lowest dosage to the desired therapeutic effects.
Patients treated with pituitary irradiation should be withdrawn from bromocriptine therapy on a yearly basis to assess both the clinical effects of radiation on the disease process as well as the effects of bromocriptine. Usually a 4 to 8 week withdrawal period is adequate for this purpose.
Dosage selection in the elderly should be cautious, starting at the lower end of the dose range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy in this population.
Bromocriptine is contraindicated for use in patients with uncontrolled hypertension due to risk of acute myocardial infarction. It is also contraindicated for use in the prevention of physiological lactation.
Bromocriptine should be used with caution in patients with a history of psychosis or cardiovascular disease.
Since hyperprolactinemia with amenorrhea/galactorrhea and infertility have been reported in patients with pituitary tumors, a complete pituitary evaluation is recommended prior to bromocriptine administration.
Because pregnancy may occur prior to reinitiation of menses, a pregnancy test is recommended at least every 4 weeks during the amenorrheic period, and once menses are reinitiated, every time a patient misses a menstrual period.
Patients not seeking pregnancy, or those harboring large adenomas, should be advised to use contraceptive measures, other than oral contraceptives, during treatment with bromocriptine.
In patients receiving treatment for hyperprolactinemia, bromocriptine should be withdrawn when pregnancy is diagnosed. In the event that bromocriptine is reinstituted to control a rapidly expanding macroadenoma, and a patient experiences a hypertensive disorder of pregnancy, the benefit of continuing bromocriptine must be weighed against the possible risk of its use during a hypertensive disorder of pregnancy.
In some patients, during the treatment of hyperprolactinemic states, a secondary deterioration of visual fields may subsequently develop despite normalized prolactin levels and tumor shrinkage, which may result from traction on the optic chiasm which is pulled down into the now partially empty sella. In these cases the visual field defect may improve on reduction of bromocriptine dosage while there is some elevation of prolactin and some tumor re-expansion. Close monitoring of patients with macroprolactinoma is recommended for an early recognition of secondary field loss due to chiasmal herniation and drug dosage modification.
When bromocriptine is used to treat acromegaly or Parkinson's disease in patients who subsequently become pregnant, a decision should be made as to whether the therapy continues to be medically necessary or can be withdrawn. If it is continued, the drug should be withdrawn in those in those who may experience hypertensive disorders of pregnancy (including eclampsia, preeclampsia, or pregnancy-induced hypertension) unless withdrawal of bromocriptine is considered to be medically contraindicated.
The abrupt discontinuation of bromocriptine in Parkinson's disease patients has triggered the occurrence, very rarely, of a syndrome resembling Neuroleptic Malignant Syndrome.
Bromocriptine administration during pregnancy may expand prolactin-secreting adenomas resulting in compression of the optic or other cranial nerves, facilitating the necessity for emergency pituitary surgery. However, in most cases, the compression resolves following delivery, and reinitiation of bromocriptine administration has been reported to produce visual field improvement.
Blood pressure levels should be monitored regularly, especially during the first weeks of therapy. Severe headache, hypertension, seizures, stroke, and myocardial infarction have occurred sometimes at the initiation of therapy. Particular attention should be paid to those patients who have recently received other drugs that can alter the blood pressure. Caution should be exercised when treating patients receiving antihypertensive drugs because symptomatic hypotension can occur. If hypertension, severe, progressive, or un remitting headache (with or without visual disturbance), or evidence of CNS toxicity develops, drug therapy should be discontinued and the patient should be evaluated promptly.
Long-term treatment (6 to 36 months) with bromocriptine in doses ranging from 20 mg to 100 mg/day has been associated with pulmonary infiltrates, pleural effusion, and thickening of the pleura in a few patients. Upon discontinuation of bromocriptine, these changes slowly reverted towards normal.
Cold sensitive digital vasospasm has been observed in some acromegalic patients treated with bromocriptine. These events can be reversed by reducing the dose of bromocriptine and may be prevented by keeping the fingers warm.
Cases of severe gastrointestinal bleeding from peptic ulcers, some fatal, have been reported by acromegalic patients treated with bromocriptine. Although there is no evidence that bromocriptine increases the incidence of peptic ulcers in acromegalic patients, symptoms suggestive of peptic ulcer should be investigated and treated appropriately. Patients with a history of peptic ulcer or gastrointestinal bleeding should be observed carefully during treatment with bromocriptine.
Possible tumor expansion has been reported in a few patients receiving bromocriptine for the treatment of acromegaly. Since the natural history of growth hormone secreting tumors is unknown, all patients should be carefully monitored and, if evidence of tumor expansion develops, the drug should be discontinued and alternative procedures considered.
High doses of bromocriptine may be associated with confusion and mental disturbances. Since parkinsonian patients may manifest mild degrees of dementia, caution should be used when treating such patients.
Retroperitoneal fibrosis has been reported in a few patients receiving long-term therapy (2 to 10 years) with bromocriptine in doses ranging from 30 to 140 mg daily.
Data not available
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